- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07525050
The Breakfast Study: How Different Aspects of Food Affect Eating
June 2, 2026 updated by: Julie Hess, USDA Grand Forks Human Nutrition Research Center
Impact of a Healthy Meal Containing Mostly Ultra-processed Foods Compared to a Healthy Meal With Less-processed Foods on Satiety and Eating Behaviors
The purpose of this research study is to test how different aspects of food including food processing affect eating behaviors.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The purpose of this project is to begin to address the current gap in research on ultra-processed foods (UPFs) and satiety with an acute feeding study that compares nutrient-dense meals containing mostly UPFs or "minimally processed" foods (MPFs) (mostly meaning ≥80% kcal) with similar food types and texture and macronutrient content to assess potential impacts on satiety, eating rate, food palatability, acceptance, and oral processing behaviors.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Julie Hess, PhD
- Phone Number: 701-795-8146
- Email: julie.hess@usda.gov
Study Locations
-
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North Dakota
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Grand Forks, North Dakota, United States, 58203
- USDA ARS Grand Forks Human Nutrition Research Center
-
Contact:
- Angela J Scheett, MPH, RDN
- Phone Number: 701-795-8386
- Email: angela.scheett@usda.gov
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- do not have restrictive eating practices
- regularly consume breakfast
- able to understand and sign the consent form
- have own transportation to the research center
- not allergic to study foods or unwilling to eat them
- willing to comply with study demands
- able to read and understand English
- available to attend two in-person visits on a weekday and/or Saturday morning from 7:15 a.m. to 12:15 p.m.
Exclusion Criteria:
- taking statins, medication to lower blood pressure, anti-inflammatory, anti-diabetes, or weight-loss medications
- pregnant, lactating, or planning to become pregnant
- diagnosed with an eating disorder, hypothyroidism, or cancer
- allergy to study foods or express unwillingness to consume them
- have gained or lost more than 10 pounds in the last 3 months
- regular participants in vigorous endurance or resistance exercise (e.g., marathons, endurance bike races, triathlons, CrossFit, powerlifting)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: UPF breakfast then MPF breakfast
Participants will consume the UPF breakfast during the first study visit and the MPF breakfast during the second study visit
|
Participants will be provided with the UPF breakfast during the first study visit and the MPF breakfast during the second study visit
|
|
Experimental: MPF breakfast then UPF breakfast
Participants will consume the MPF breakfast during the first study visit and the UPF breakfast during the second study visit
|
Participants will be provided with the MPF breakfast during the first study visit and the UPF breakfast during the second study visit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in satiety as determined by visual analogue scales (VAS)
Time Frame: Day 1, Day 15
|
Participants will complete visual analogue scales (VAS) on satiety measures during each study visit.
VAS are represented by 100mm lines anchored at each end by descriptive extremes.
For satiety, these extremes are statements about desire to eat (very weak; very strong), hunger (not hungry; as hungry as I've ever felt), fullness (not full; totally full), satisfied (completely empty; cannot eat another bite), prospective consumption (not at all; a large amount).
Participants indicate via marks on the VAS line the extent to which they experience each sensation at a given timepoint.
Measurements are tracked across time and plotted on a graph from baseline to the time preceding the next meal and the area under the curve above the baseline measurement is calculated.
|
Day 1, Day 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Julie Hess, PhD, USDA Grand Forks Human Nutrition Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
April 6, 2026
First Submitted That Met QC Criteria
April 6, 2026
First Posted (Actual)
April 13, 2026
Study Record Updates
Last Update Posted (Actual)
June 4, 2026
Last Update Submitted That Met QC Criteria
June 2, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- GFHNRC220
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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